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Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
carboplatin
cisplatin
docetaxel
etoposide
paclitaxel
vinblastine sulfate
vinorelbine tartrate
gene expression analysis
positron emission tomography
fludeoxyglucose F 18
radiation therapy
Sponsored by
American College of Radiology Imaging Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC) Clinical stage IIB or III disease No small cell carcinoma No stage IV disease* No diffuse bronchoalveolar subtype No planned definitive surgical resection NOTE: *Patients with evidence of stage IV disease by positron emission tomography are eligible if the evidence cannot be confirmed by other means AND the physician still plans to proceed with definitive chemoradiation Planning treatment with definitive chemoradiotherapy May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy No brain metastases by head CT scan or MRI PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy) Able to tolerate positron emission tomography imaging No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy Chemotherapy See Disease Characteristics No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics No prior thoracic radiotherapy No concurrent intensity-modulated radiotherapy Surgery See Disease Characteristics

Sites / Locations

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
  • Scottsdale Medical Imaging, Limited
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Radiological Associates of Sacramento Medical Group at Sutter Cancer Center
  • Hospital of Saint Raphael
  • Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital
  • North Broward Medical Center
  • Integrated Community Oncology Network at Baptist Cancer Institute
  • Tallahassee Memorial Hospital
  • Rush Cancer Institute at Rush University Medical Center
  • Saint John's Cancer Center at Saint John's Medical Center
  • Center for Cancer Care at Goshen General Hospital
  • CCOP - Northern Indiana CR Consortium
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Dana-Farber Partners Cancer Care
  • Beth Israel Deaconess Medical Center
  • South Shore Hospital
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • West Michigan Cancer Center
  • William Beaumont Hospital - Royal Oak Campus
  • Mallinckrodt Institute of Radiology at Washington University Medical Center
  • Renown Institute for Cancer at Renown Regional Medical Center
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
  • J. Phillip Citta Regional Cancer Center at Community Medical Center
  • McDowell Cancer Center at Akron General Medical Center
  • Cleveland Clinic Cancer Center at Fairview Hospital
  • Cleveland Clinic Taussig Cancer Center
  • Oklahoma University Cancer Institute
  • Knight Cancer Institute at Oregon Health and Science University
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Fox Chase Cancer Center - Philadelphia
  • Albert Einstein Cancer Center
  • UPMC Cancer Centers
  • Lankenau Cancer Center at Lankenau Hospital
  • Roger Williams Medical Center
  • Brown University School of Medicine
  • Hollings Cancer Center at Medical University of South Carolina
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  • Vanderbilt-Ingram Cancer Center
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • M. D. Anderson Cancer Center at University of Texas
  • Huntsman Cancer Institute at University of Utah
  • Bon Secours Cancer Institute at St. Mary's Hospital
  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  • Waukesha Memorial Hospital Regional Cancer Center
  • Tom Baker Cancer Centre - Calgary
  • Grand River Regional Cancer Centre at Grand River Hospital
  • National Cancer Center - Korea

Outcomes

Primary Outcome Measures

Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution

Secondary Outcome Measures

Relationship of survival to post-treatment max SUV as determined by the imaging institute
Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution
Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution
Reliability between peak and max SUV measurements both pre- and post-treatment
Proportion of participants who are either upstaged or downstaged by positron emission tomography scan
Reliability between PET scan-defined response to therapy measurements
Correlation of Ki-67 expression with peak and max pre-treatment SUV
Association between Ki-67 expression and overall survival at 2 years

Full Information

First Posted
May 14, 2004
Last Updated
February 26, 2011
Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI), Radiation Therapy Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00083083
Brief Title
Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
Official Title
Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
June 2006 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI), Radiation Therapy Oncology Group

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's response to treatment and plan more effective treatment. PURPOSE: This phase II trial is studying how well ^18FDG-PET imaging works in detecting disease progression and determining response to treatment in patients who are undergoing chemoradiotherapy for locally advanced non-small cell lung cancer.
Detailed Description
OBJECTIVES: Primary Determine whether peak standardized uptake value (SUV) for fludeoxyglucose F 18 positron emission tomography (FDG-PET) shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer. Secondary Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients. Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients. Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients. Correlate, if possible, Ki-67 expression with overall survival of patients assessed with these imaging techniques. OUTLINE: This is a diagnostic, multicenter study. Before starting chemoradiotherapy, patients undergo baseline whole-body positron emission tomography (PET) imaging. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed 50-70 minutes later by PET imaging. Patients then receive concurrent definitive radiotherapy and chemotherapy. Patients enrolled in other treatment-oriented clinical trials receive therapy as per that trial. Other patients receive standard thoracic radiotherapy (dose ≥ 60 Gy) and standard chemotherapy comprising a platin (cisplatin or carboplatin) and a second non-platin, non-gemcitabine drug (etoposide, vinblastine, vinorelbine, paclitaxel, or docetaxel). Approximately 14 weeks after completion of chemoradiotherapy and adjuvant chemotherapy (if given), patients undergo post-treatment ^18FDG-PET imaging. Patients are followed every 3 months for 2 years and then every 6 months for at least 1 year. PROJECTED ACCRUAL: A total of 250 patients (including at least 75 with stage IIB/IIIA disease and at least 75 with stage IIIB disease) will be accrued for this study within 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
vinblastine sulfate
Intervention Type
Drug
Intervention Name(s)
vinorelbine tartrate
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution
Secondary Outcome Measure Information:
Title
Relationship of survival to post-treatment max SUV as determined by the imaging institute
Title
Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution
Title
Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution
Title
Reliability between peak and max SUV measurements both pre- and post-treatment
Title
Proportion of participants who are either upstaged or downstaged by positron emission tomography scan
Title
Reliability between PET scan-defined response to therapy measurements
Title
Correlation of Ki-67 expression with peak and max pre-treatment SUV
Title
Association between Ki-67 expression and overall survival at 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC) Clinical stage IIB or III disease No small cell carcinoma No stage IV disease* No diffuse bronchoalveolar subtype No planned definitive surgical resection NOTE: *Patients with evidence of stage IV disease by positron emission tomography are eligible if the evidence cannot be confirmed by other means AND the physician still plans to proceed with definitive chemoradiation Planning treatment with definitive chemoradiotherapy May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy No brain metastases by head CT scan or MRI PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy) Able to tolerate positron emission tomography imaging No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy Chemotherapy See Disease Characteristics No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics No prior thoracic radiotherapy No concurrent intensity-modulated radiotherapy Surgery See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Machtay, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Study Chair
Facility Information:
Facility Name
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Scottsdale Medical Imaging, Limited
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85262
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
Radiological Associates of Sacramento Medical Group at Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Hospital of Saint Raphael
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
North Broward Medical Center
City
Dearfield Beach
State/Province
Florida
ZIP/Postal Code
33064-3596
Country
United States
Facility Name
Integrated Community Oncology Network at Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Rush Cancer Institute at Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Saint John's Cancer Center at Saint John's Medical Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
Center for Cancer Care at Goshen General Hospital
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana-Farber Partners Cancer Care
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
South Shore Hospital
City
South Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Mallinckrodt Institute of Radiology at Washington University Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Renown Institute for Cancer at Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
J. Phillip Citta Regional Cancer Center at Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
McDowell Cancer Center at Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Cleveland Clinic Cancer Center at Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Knight Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
UPMC Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Lankenau Cancer Center at Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Roger Williams Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908-4735
Country
United States
Facility Name
Brown University School of Medicine
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Bon Secours Cancer Institute at St. Mary's Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Waukesha Memorial Hospital Regional Cancer Center
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Tom Baker Cancer Centre - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Grand River Regional Cancer Centre at Grand River Hospital
City
Kitchner
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
National Cancer Center - Korea
City
Goyang
ZIP/Postal Code
410-769
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

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